Premia Spine Ltd.

1. Compliance with Post Market Surveillance (PMS) obligations 2. Compliance with the Vigilance Reporting obligations 3. Issuance of a signed statement (for Investigational devices): that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.

1. Conformity of the device to the Medical Device Regulation and Quality Management System in which the devices are manufactured, before a device is released. 2. Technical Documentation and EU Declaration of conformity are drawn up and kept up to date.